SPI-1005 for the Treatment of Meniere's Disease (Open Label)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSound Pharmaceuticals, Incorporated
About this trial
Study of the safety of open-label SPI-1005 400 mg BID treatment in adults with Meniere's Disease (MD) for 6 or 12 months to support chronic or chronic intermittent use.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult males/females, 18-75 years of age at the time of enrollment.
Diagnosis of probable or definite Meniere's Disease by AAO-HNS Amended 2015 Criteria.
At least two of three active symptoms (fluctuating hearing; tinnitus; aural fullness; vertigo or dizziness) of Meniere's disease, within 3 months of study enrollment.
Type A tympanogram at screening.
Disqualifiers
Current, or within 60 days prior to study enrollment, use of IV or intratympanic ototoxic medications such as chemotherapy including cisplatin, carboplatin, or oxaliplatin; aminoglycoside antibiotics including gentamicin, amikacin, tobramycin, kanamycin, or streptomycin; or loop diuretics including furosemide.
History of otosclerosis or vestibular schwannoma.
History of significant middle ear or inner ear surgery in the affected ear.
Conductive hearing loss with air-bone gap ≥15 dB, otitis media, or mixed hearing loss.
Trial design
Design model
Single group
Treatments tested in this trial
Ebselen
DrugGlutathione peroxidase mimetic
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Open LabelExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events
Safety and tolerability assessed based on adverse events
Time frame
180 and 360 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov